Core Viewpoint - Innovent Biologics has presented promising clinical data for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, demonstrating breakthrough efficacy in treating "immune cold tumors" such as acral and mucosal melanoma, which are traditionally resistant to treatment [1][2][4]. Company Overview - Innovent Biologics is a leading biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, cardiovascular, and autoimmune conditions [16]. - The company has launched 15 products and has multiple assets in various stages of clinical trials, indicating a robust pipeline [16]. Clinical Study Insights - IBI363 is currently undergoing clinical studies in China, the United States, and Australia, targeting multiple tumor indications, particularly immune-resistant and cold tumors [2][14]. - The Phase 1/2 studies have shown a confirmed objective response rate (cORR) of 23.3% and a disease control rate (DCR) of 76.7% in patients with advanced melanoma [6][7]. - The median progression-free survival (PFS) for patients treated with IBI363 was reported at 5.7 months, significantly longer than previous studies [7][10]. Efficacy and Safety Profile - IBI363 has demonstrated durable responses with a median duration of response (DoR) of 14.0 months in patients with confirmed responses [7]. - The overall 12-month overall survival (OS) rate was 61.5%, with a median OS of 14.8 months [6][7]. - The treatment was generally well tolerated, with the most common treatment-related adverse events being arthralgia, rash, and hyperthyroidism, primarily Grade 1 or 2 [7]. Future Development Plans - A pivotal Phase 2 registrational study comparing IBI363 with pembrolizumab in patients with unresectable melanoma has been initiated, aiming to enroll 180 patients [8][9]. - The company is also exploring combination therapies with IBI363 across various cancer types, indicating a commitment to expanding its therapeutic applications [9][14]. Market Need and Potential - There is a significant unmet clinical need for effective treatments for advanced acral and mucosal melanoma in China, where current therapies have limited efficacy [10][12]. - IBI363 aims to address this gap by transforming "cold tumors" into "hot tumors" through dual activation of the PD-1 and IL-2 pathways, potentially establishing a new standard in immunotherapy for melanoma [10][13].
ASCO 2025 Oral Presentation: Innovent Biologics Announces Updated Data of IBI363 (First-in-class PD-1/IL-2α -bias Bispecific Antibody Fusion Protein) from Phase 1 and 2 Clinical Studies on Immunotherapy-treated Advanced Malignant Melanoma